LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Department Quality Assurance
Title In-Process Analysis Request & Report Sheet
Powder for Suspension MO No.:

From: Production Department To: QA Department

Product Name : Polyxim PFS 50 ml Batch No.:
Product Code : PXPS03 Batch Size:
Product Strength : Cefixime Trihydrate USP (111.9 + Overage 2.5 %) mg / 5 ml QC Ref No.:

Sl. Production Department Quality Control Department

No.
01. ANALYSIS REQUEST SPECIFICATIONS ANALYSIS REPORT
Interim report after Blending:
1. Appearance 1. An off- white powder. 1.
2. Identification 2. Must comply with the identification test of Cefixime. 2.
3. Loss on drying 3. Not more than 1.5 %w/w. 3.
4. Blend uniformity 4. Complies with BP 2007 limit. 4.
5. Assay 5. 4.524 % 2.5 % (4.41 % and 4.637 %) of Cefixime Trihydrate. 5.
6. Advised weight per phial 6. 25.35 mg 2.5 % ( 24.72 gm and 25.98 gm. 6.

Remarks:
Signature & Date:____________ Signature (QC) & Date:________________________

02. Interim report after Reconstitution:

1. An off-white viscous suspension.
1. Appearance 1.
2. Orange flavour.
2. Odour 2.
3. Palatable.
3. Taste 3.
4. 3.5 to 4.5.
4. pH 4.
5. 49.0 ml to 51.0 ml.
5. Volume 5.
6. 1.15 g/ml to 1.30 g/ml.
6. Weight per ml 6.
Remarks:
Signature & Date:_____________ Signature (QA) & Date:________________________

03. Interim report after Sealing:

1. Leak Test 1. Must be Leak Proof. 1.

Remarks:
Signature & Date:_____________ Signature (QA) & Date:________________________

04. Final report after Packing:

1. Batch No. 1. . 1.
2. Mfg. Date & Exp. Date 2. Mfg. Date: .. & Exp. Date: ... 2.
3. Price 3. 3.
Remarks:
Signature & Date:_____________ Signature (QA) & Date:________________________

Checked By: ____________________ Date: ______________________

Form No.: QA/FORM/IPC/PXPS03 Version: 01 Effective Date: 01.06.2014